Antidiabetic Vildagliptin, Bioequivalence
Conditions
Interventions
Test product of vildagliptin,Reference product of vildagliptin
Experimental Drug,Active Comparator Drug
Vildagliptin (Test Product),Galvus 50 mg
Sponsors
T.O. Chemicals (1979) Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Male/Female must be 18-55 years of age, body mass index (BMI) = 18.0-25.0 kg/m2, inclusive. 2. Must be in good health as determined by medical history, vital signs and physical examination or showing no clinically significant abnormalities in the opinion of clinical investigator 3. Screening ECG without clinically significant abnormalities 4. Screening visit laboratory values of blood test must be within the normal range or showing no clinically significant abnormalities in the opinion of clinical investigator. 5. Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of clinical investigator. 6. Must have serum hepatitis B surface antigen (HBsAg) seronegative. 7. Female subjects must have serum B-hCG negative or is not pregnant or breast feeding. 8. Non-smokers (never smoked or no smoking within the previous 1 year). 12. Have the ability to understand the requirements of the study and must voluntarily sign and date an informed consent, approved by an Independent Ethic Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to vildagliptin and its components 2. Past medical history of renal and hepatic insufficiency. 3. Subject has a history of any illness 4. Have history of drug abuse in the opinion of the investigator, as judged by medical history) in the last 12 months. 5. Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months. 6. Participation in any investigation drug study within 1 month from screening (from the last follow-up visit to the screening).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vildagliptin level in plasma At pre-dose, Day1 and Day 2 (21 Time points) Pharmacokinetic parameters: AUC0-t, AUC0-inf, Cmax, tmax of vildagliptin | — |
Secondary
| Measure | Time frame |
|---|---|
| N/A N/a N/A | — |
Countries
Thailand
Contacts
Public ContactAriya Khunvichai
Medica Innova Co., Ltd.
Outcome results
None listed